Alembic Pharmaceuticals Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg. The approval strengthens the company’s growing portfolio in the regulated US generics market and marks another milestone in its global pharmaceutical expansion strategy.
The approved ANDA is therapeutically equivalent to the reference listed drug, Nubeqa Tablets, 300 mg, marketed by Bayer HealthCare Pharmaceuticals Inc. Darolutamide is an androgen receptor inhibitor used in the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and metastatic castration-sensitive prostate cancer in combination with docetaxel therapy.
The medication is part of advanced treatment protocols aimed at managing prostate cancer progression in multiple stages of the disease. According to IQVIA data for the twelve months ending March 2026, the estimated market size for Darolutamide Tablets, 300 mg, in the United States stands at approximately US$ 3.15 billion, highlighting a significant commercial opportunity in the oncology therapeutics segment.
With this latest development, Alembic Pharmaceuticals has received a cumulative total of 238 ANDA approvals from the USFDA, including 219 final approvals and 19 tentative approvals. The company continues to strengthen its presence in regulated international markets through sustained investments in research, development, manufacturing, and compliance infrastructure.
Alembic Pharmaceuticals stated that the approval reflects its continued focus on developing complex and high-value generic formulations catering to global healthcare requirements. The company has been steadily expanding its oncology and specialty product portfolio as part of its long-term growth strategy in regulated markets.
Established in 1907, Alembic Pharmaceuticals is one of India’s longstanding pharmaceutical companies with operations spanning branded formulations, active pharmaceutical ingredients, and generic medicines. Headquartered in India, the company manufactures and markets pharmaceutical products across multiple global markets.
Alembic operates vertically integrated research and manufacturing facilities approved by several international regulatory authorities, including the USFDA. Its facilities support the development and production of oral solids, injectables, oncology products, and specialty formulations for domestic and international markets.
Alembic Pharmaceuticals continues to focus on expanding its regulated market portfolio while strengthening its research capabilities across complex generics and specialty therapies. The company remains committed to delivering accessible and affordable healthcare solutions across global markets through innovation, quality manufacturing, and regulatory compliance.
